Lung-MAP S1400: Lung Master Protocol rolls to the launch pad
What do you call five randomized studies of targeted investigational agents for squamous cell lung cancer rolled into one overarching clinical trial under a single genomic screening assay? The lung master protocol, of course, or Lung-MAP. As S1400 activation approaches, here's what you need to know to get started.
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STUDY UPDATE

S1400: Lung-MAP, the Lung Master Protocol, coming soon

Lung-MAP Launch in San Francisco

An S1400 kickoff training session will take place at the spring group meeting in San Francisco on Friday, May 2, 6:00-7:30 pm, featuring brief presentations by study chairs, statisticians, data management staff, and more. This session will fulfill the training requirement you'll need to meet before you can enroll patients to S1400; you can attend in-person or complete the module online later. You'll leave the San Francisco session with the knowledge and tools to generate excitement about launching Lung-MAP at your institution!

SWOG S1400 -- the Lung Master Protocol, or Lung-MAP -- is expected to activate this spring. Given the trial framework and the unprecedented scope of collaboration behind it, this will be a landmark study from the day it launches.

Lung-MAP is a large scale, phase II/III screening/clinical registration protocol that will genomically screen patients with advanced stage lung squamous cell cancer moving to second-line therapy, and will use the screening results to direct each patient to the most appropriate one of five (or more) sub-studies. Patients on each sub-study will be randomized to either standard of care (docetaxel or erlotinib) or biomarker-driven targeted therapy with an investigational agent.

Each Lung-MAP sub-study is designed around a genotypically defined alteration in the tumor and a drug that targets it. Each sub-study will function autonomously, will open and close independently, and will be independently powered for overall survival (OS) with an interim analysis for progression-free survival (PFS) to determine whether to proceed from Phase II into Phase III. When an endpoint for a sub-study is met, that drug-biomarker specific combination may proceed to FDA for approval review of the new drug with its matching companion diagnostic. When an endpoint is not met, that sub-study will be closed and another modular sub-study of a different agent will be initiated.

SWOG's Lung-MAP partners

National Cancer Institute's National Clinical Trials Network

Foundation for the National Institutes of Health

Friends of Cancer Research

Amgen

Genentech

Pfizer

AstraZeneca

MedImmune

Foundation Medicine

multiple lung cancer advocacy organizations

Patients with tumors that do not match a drug-biomarker combination will be assigned to a "non-match" sub-study and randomized to either treatment with a designated "non-match" drug (initially an immunotherapy agent targeting PD-L1) or standard of care.

Central genomic screening testing will be performed on archival fresh frozen paraffin-embedded (FFPE) tumor to establish biomarker status within 10-14 days of screening. S1400's five sub-studies are designed to accrue a total of 400-800 patients (from 500-1,000 screened) per year over at least two years.

Lung-MAP is the result of an unprecedented public-private collaboration between government, non-profit, and for-profit organizations. If this Master Protocol strategy is successful, it could serve as a prototype for drug registration in other settings.

An S1400 kickoff training session will take place at the spring group meeting in San Francisco on Friday, May 2, 6:00-7:30 pm, featuring brief presentations by study chairs, statisticians, data management staff, and more. You'll leave the session with the knowledge and tools to generate excitement about launching Lung-MAP at your institution.